MAUDE Adverse Event Report: BIOMET 3I T3¿ PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 10MM (L); DENTAL IMPLANT

Catalog Number	T3ST3210
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reports that the cover screw size was incorrect and became stuck inside the implant and could not be removed, so the implant also had to be taken out.The procedure was not completed by placing a new implant.The affected tooth position is number 27 and the bone type is iii.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.A4: patient weight: unknown / not provided.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report, b5: describe event or problem, d3: email address, g1: contact office - first/given name, last name and email address, g1: contact office - manufacturer site - email address, g3: date received by manufacturer, g6: type of report, h1: type of reportable event, h2: follow up type, h3: device evaluated by manufacturer, h6: adverse event problem, h10: additional narrative.Zimvie received one (1) t3st3210, (t3 pro non-platform switched tapered implant 3.25mm (d) x 10mm (l) for evaluation.Visual evaluation and a functional test were performed, the implant had signs of use with bone debris on its external threads.The cover screw disengaged from the implant.The cover screw returned was not the bundled cover screw that comes with the implant.The cover screw was a icsf41 for wider implant.The implants packaging was not returned.There was no damage to the icsf41, therefore it was recorded as a concomitant.Dhr review was completed for the subject lot number 2120020710.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2120020710 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: functional: does not disengage/release¿ based on the investigation and risk management file review, the most likely root cause determined was improper handling of product outside of zimvie controls.Therefore, based on the available information, a device malfunction could not be verified.A icsf41 cover screw was returned attached to the implant.During a functional test, the cover screw disengaged from the implant.The reported event is non-verifiable since the condition of the product/packaging received by the customer was unknown.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: T3¿ PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 10MM (L)
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 22910669
• Report Number: 0001038806-2025-02040
• Device Sequence Number: 15717155
• Product Code: DZE
• UDI-Device Identifier: 00844868046868
• UDI-Public: (01)00844868046868(17)291010(10)2120020710
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K213672
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: T3ST3210
• Device Lot Number: 2120020710
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic